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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042360
Receipt No. R000048357
Scientific Title Prospective Study Evaluating Efficacy and Safety of Olanzapine and Aprepitant for Cisplatin-induced Nausea and Vomiting in Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma
Date of disclosure of the study information 2020/11/05
Last modified on 2020/11/05

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Basic information
Public title Prospective Study Evaluating Efficacy and Safety of Olanzapine and Aprepitant for Cisplatin-induced Nausea and Vomiting in Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma
Acronym PROACT study
Scientific Title Prospective Study Evaluating Efficacy and Safety of Olanzapine and Aprepitant for Cisplatin-induced Nausea and Vomiting in Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma
Scientific Title:Acronym PROACT study
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of olanzapine for cisplatin-induced nausea and vomiting in patients with hepatocellular carcinoma treated with hepatic arterial infusion chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Complete response (CR) rate within 120 hours in patients treated with olanzapine
Key secondary outcomes 1) CR rate, complete control (CC) rate and total control (TC) rate within 24 hours
2) CR rate, CC rate and TC rate within 24-120 hours
3) Numerical rating scale scores of nausea, vomiting and anorexia on day 1-6
4) Frequency of vomiting within 120 hours
5) Frequency of rescue antiemetic treatment within 120 hours
6) Frequency, severity and timing of adverse events due to antiemetic treatment
7) Child-Pugh score and ALBI score at 2 weeks and 1 month after treatment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 <Initial treatment(1)>
Granisetron (GRA) 3mg, just before treatment
Olanzapine (OLA) 5mg, in the morning on day 1 and before bedtime on day 1-4
Interventions/Control_2 <Initial treatment(2)>
GRA 3mg, just before treatment
Interventions/Control_3 <Second treatment(1)>
In addition to initial treatment,
aprepitant (APR) 125mg, in the morning on day 1
APR 80mg, in the morning on day 2, 3
Interventions/Control_4 <Second treatment(2)>
Same as initial treatment
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) 20 years old or more
2) diagnosed of HCC according to the JSH guideline (2017)
3) CDDP-HAIC planned within 7 days
4) no prior HAIC within 3 months
5) informed consent obtained
Key exclusion criteria 1) pregnant, possibly pregnant or breastfeeding
2) regular use of olanzapine or other antipsychotic drugs
3) previous participation in this study
4) moderate or severe (NRS 4 or more) nausea
5) considered not appropriate for participating in this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Masayuki
Middle name
Last name Ueno
Organization Kurashiki Central Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 710-8602
Address 1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL 086-422-0210
Email mu13951@kchnet.or.jp

Public contact
Name of contact person
1st name Masayuki
Middle name
Last name Ueno
Organization Kurashiki Central Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 710-8602
Address 1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL 0864220210
Homepage URL
Email mu13951@kchnet.or.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Kurashiki Central Hospital
Institute
Department

Funding Source
Organization No funding source
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical Ethics Committee, Kurashiki Central Hospital
Address 1-1-1 Miwa, Kurashiki, Okayama, Japan
Tel 086-422-0210
Email kenkyu@kchnet.or.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 05 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2020 Year 10 Month 14 Day
Date of IRB
2020 Year 11 Month 04 Day
Anticipated trial start date
2020 Year 11 Month 05 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2023 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2020 Year 11 Month 05 Day
Last modified on
2020 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048357

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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